Cleared Traditional

K896634 - CARAGLAS XTRA SYNTHETIC CASTING TAPE (FDA 510(k) Clearance)

Class I Orthopedic device.

K896634 · Buckman Co., Inc. · Orthopedic device
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Jun 1990
Decision
204d
Days
Class 1
Risk

K896634 is an FDA 510(k) clearance for the CARAGLAS XTRA SYNTHETIC CASTING TAPE. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on June 14, 1990 after a review of 204 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5940 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Buckman Co., Inc. devices

Submission Details

510(k) Number K896634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1989
Decision Date June 14, 1990
Days to Decision 204 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 122d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGF Component, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5940
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.